Drug Facts

Active Ingredient:

Menthol 3.00%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Warning

For external use only.

Do not use if

allergic to any ingredients listed in this product.

When using this product

• Use only as direcred • Avoid contact with eyes and mucous membranes • Do not apply directly to wounds or broken skin • Do not bandage tightly or use a heating pad.

Stop use and ask a doctor if

• Condition worsens • Condition persists for more than 7 days or clears up and occurs again within a few days.

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, seek medical attention or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

• Apply and massage a thin layer to affected area no more than 3 to 4 times daily.

• Wash hands with soap and water after applying.

Ask a doctor. Children under 12:

Other information

• Store at 15°-25° C (59°-77°F) • Protect from heat. • Keep tightly closed.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, GLycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel) Extract, Hydroxyethyl Cellulose, Ilex Paraguariensis (Yerba Mate') Extract, Isopropyl Myristate, Methylsulfonulmethane (MSM), Phenoxyethanol, Propylene Glycol, Triethanolamine.

Package Labeling:

Label

ARNIMAX PENETRATING PAIN RELIEF GEL
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:35324-274
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:35324-274-00	1 in 1 BOX	02/15/2022
1		75 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	02/15/2022

Labeler - WYNNPHARM INC. (620885173)

ARNIMAX Penetrating Pain Relief Gel